CLASS II Drug recall · Reported 30 Jun 2021 · FDA Enforcement Report

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops recalled

Hill Dermaceuticals is recalling DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops, distributed nationwide in the US. The recall was initiated on 21 May 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22

NDC68791-103

Quantity recalled34,561 bottles for sale; 773 bottles for samples

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0637-2021
FDA event ID: 87990
Recalling firm: Hill Dermaceuticals, Sanford, FL
Brand: Dermotic
Manufacturer: Royal Pharmaceuticals
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2021
FDA classified: 23 Jun 2021
Reported: 30 Jun 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material

Timeline

21 May 2021	Recall initiated by company
23 Jun 2021	Classified by FDA	+33 days
30 Jun 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx only, Manufactured by: Hill Dermaceuticals, Inc. Sanford, FL 32773 for: Royal Pharmaceuticals Manasquan, NJ 08736, NDC 68791-103-20

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.

Which lots are affected?

Lot #: 19K036D, 19L039E Exp. 05/21; 20A001E, 20A003D, 20A003E, Exp. 07/21; 20C013G Exp. 09/21; 20E025F, 20E025G, 20E025H Exp. 12/21; 20H041D, 20H041F Exp. 02/22; 20J043E Exp. 03/22; 20K050F Exp. 04/22; 20L055E Exp. 06/22; 21C015E, 21C018E Exp. 09/22

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hill Dermaceuticals

All 17

Reported	Class	Recall	Company	Reason	Where
2 Apr 2014Drug	CLASS III	Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fs	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Seton Pharmaceuticals Fluocinolone Acetonide 0.01% Topical recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Royal Pharmaceuticals Derma-Smoothe/FS fluocinolone recalledDerma-smoothe/fs	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops recalled	Hill Dermaceuticals	Potency & Assay	Nationwide
2 Apr 2014Drug	CLASS III	Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil recalled	Hill Dermaceuticals	Potency & Assay	Nationwide

Other Fluocinolone Acetonide recalls

All 14

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026Drug	CLASS III	Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
31 Jan 2024Drug	CLASS II	Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package recalledFluocinolone Acetonide	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
30 Jan 2019Drug	CLASS II	Fluocinolone Acetonide Topical Solution, USP, 0.01 % recalledFluocinolone Acetonide	Lupin Somerset	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Fluocinolone Acetonide Topical Solution recalled by Lupin SomersetFluocinolone Acetonide	Lupin Somerset	Potency & Assay	Nationwide
18 Jul 2018Drug	CLASS II	Fluocinolone Acetonide Topical Solution recalledFluocinolone Acetonide Topical	Teva Pharmaceuticals USA	Potency & Assay	Nationwide